1. Field of the Invention
This invention relates to a method for forming an antidotal food product containing activated charcoal that is administered to poisoning victims for decontamination of various poisonous substances that may have been ingested. In particular, this invention relates to a method of producing an antidotal food product containing activated charcoal that is an orally administered antidotal substance having the visual appearance and physical properties to entice proper oral administration to even young children.
More in particular, this invention is directed to a method for forming an activated charcoal decontaminant food product having an appearance, texture and taste that emulates that of a baked cookie.
Still further, the method of this invention includes the steps of mixing activated charcoal with a filler, a binder and water to form a slurry; spray drying the slurry to form a granular composition; blending the granular composition with a friction reducing composition; and, compressing the blended mixture to form a dry friable wafer. Still more in particular, the method of this invention further includes the step of inserting a sweet creamy filling mixture composition between a pair of wafers to form a cookie sandwich-type food product.
2. Prior Art
Poisonings are the ingestion of toxic substances and have historically been and continue to be a significant problem today. With the ongoing proliferation of an expansive variety of commercially-available household products, access to a plethora of toxic substances in the average home is currently at or near an all-time high. While efforts in recent years, such as conspicuous labeling, tamper-proof sealing campaigns, and limiting the number of tablets in bottles of children's medicines, as well as a concerted informational program, appear to have been successful in preventing dramatic growth in the number of poisoning deaths that occur annually, significant numbers of poisoning incidents continue to occur. An overwhelming percentage of those incidents occur at a residence, and the majority of the victims tend to be young children. In 1993 alone, for instance, there were 1,751,476 human poisoning cases reported to recognized Poison Centers, over 90% of which occurred at a residence, according to the 1993 Annual Report of the American Association of Poison Control Centers Toxic Exposure Surveillance System. Children under the age of six made up approximately 56% of the victims in those cases. Considering that at that time only about 70% of the American population actually had access to a Poison Center recognized in the study, the number of incidents that actually occurred in 1993 is likely to have been significantly higher than these numbers would indicate, with the total number of cases more realistically been on the order of 2,500,000.
In the emergency treatment of poisoning victims, the effort centers around two main objectives: general support and stabilization of the victim, and decontamination of the victim. As decontamination and treatment must begin immediately in such toxicological emergencies, often without the benefit of full and thorough clinical information on the patient, it is particularly important that any drug or therapeutic substance administered to the patient be substantially free of unwanted side effects that may cause unforeseen complications, or even death. For this reason, sorbents which, when introduced into the patient's gastro-intestinal tract, resist decomposition and adsorb the ingested toxins until eventual excretion by the patient, have been employed for decontamination. Of those sorbents, activated charcoal has emerged in the field of emergency toxicological treatment as the decontaminant of choice. Its routine use in the treatment of poison victims did not become widespread until the 1980's. However, its administration to poisoning victims has now surpassed the administration of syrup of ipecac as the single most important general toxicological treatment measure.
Activated charcoal is a fine, black, powdery substance which is tasteless, odorless, and non-toxic. Activated charcoal is generally formed by oxidation (activation) of combustion residue derived from a controlled combustion process performed on wood, peat, or other organic material. The oxidation and controlled combustion steps combine to yield a substance composed of extremely porous particles which give it extraordinarily high internal surface area, typically ranging between 900 m.sup.2 /g and 2400 m.sup.2 /g. Due to its extraordinary surface area, activated charcoal exhibits great adsorptivity and, thus, has proven to be quite effective as a decontaminant when introduced in sufficient quantities into the gastro-intestinal tract of a poisoning victim. The highly adsorptive activated carbon particles within the gastro-intestinal tract are capable of adsorbing toxin, not only from the contents of the gastro-intestinal tract but even from the bloodstream (by "intestinal dialysis"), from the blood vessels which supply the gastro-intestinal tract. Those toxins become bound to the activated charcoal, and are then excreted in the stool.
Activated charcoal is currently available in several forms to be orally administered to poisoning victims. In the most widely used form, activated charcoal is contained in a suspension such as the commercially available ACTIDOSE AQUA and CHARCOAID 2000 suspensions. Activated charcoal is also available extensively in Europe, and to a more limited extent in the United States, simply in its powdered or granulated form for mixture within a drinkable liquid prior to ingestion. In yet another form, activated charcoal is contained in over-the-counter tablets or capsules widely available in Europe for the treatment of gas and upset stomach. Use of these tablets or capsules for decontamination in toxicological treatment, however, is not readily feasible. Even if all the active ingredients other than activated charcoal were removed therefrom, the relatively high dosages required in most poisoning incidents would necessitate the ingestion of many such tablets or capsules, a daunting task even for the average adult, let alone for the average young child.
In whatever form activated charcoal is delivered to the gastro-intestinal tract, suspended in a liquid, compressed within a tablet or capsule, or simply in its raw powdery state, the activated charcoal is likely to have significantly beneficial, if not life-saving, effects on the poisoning victim, if it can be properly delivered in the necessary dosage to the gastro-intestinal tract of the victim. Therein lies the single greatest obstacle to optimal utilization of activated charcoal as a decontaminant in toxicological treatment. Each of the currently available forms in which activated charcoal is available for oral ingestion utterly fails to adequately induce or at least encourage proper ingestion of a significant dose of the activated charcoal by the victim. Essentially, except for the tablet or capsule form (which presents its own obstacles to ingestion), the antidotal substances are extremely unpalatable and, quite noxious. Liquid antidotal suspensions containing activated charcoal, for instance, form a black gritty liquid bearing a striking resemblance to old engine crank case oil and lacks the pleasant taste which, theoretically, might cause the ingesting individual to even momentarily forget the unpleasant appearance, texture, and consistency of that which he or she is ingesting.
Whereas to a mature adult poisoning victim, the noxiousness of an activated charcoal-containing antidote may simply represent a trivial, though unpleasant, consequence that must be tolerated to avoid the far greater consequences of his or her serious predicament, it would hardly be such a trivial matter to a young child victim. To that young child or any other victim lacking the mental or emotional capacity to fully appreciate the magnitude of the situation and therefore incapable of seeing beyond the overbearing experience of ingesting the given antidote, the palatability of the antidote, both in appearance and taste, will not only determine how pleasant the ingestion experience is, but will actually determine whether or not the ingestion occurs in the first place. That might, in part, explain why with 1,751,476 reported poisoning incidents in 1993, activated charcoal was administered in that year to only 127,857 victims, despite the fact that the relatively risk-free benefits of activated charcoal in toxicological treatment had been widely recognized by emergency care providers since well before 1993. Children, especially very young children, who represent the class of individuals most vulnerable to accidental poisonings and who, in fact, make up the majority of the victims in poisoning incidents, are loathe to ingest activated charcoal in the various forms in which it may currently be presented to them.
This fact is borne out by empirical studies performed on the subject, and by the first-hand experiences of seasoned emergency health care professionals. For instance, in a 1987 study, Grbcich, et al., "Administration of Charcoal in the Home", Vet. Hum. Toxicology, 29, 458 (1987), the authors studied the cases of six children between the ages of one and five years who were given a liquid suspension containing 1 g/kg of activated charcoal after they had accidentally ingested a toxic substance in amounts that did not necessitate hospital treatment. Of those children, none ingested the full amount of the suspension given to him or her, and only one ingested as much as half of the amount given. The authors observed that "All parents had considerable difficulty getting the child to drink the charcoal [suspension] and most indicated they would not choose this method of oral decontamination in the event of a future poisoning." The experiences in the emergency room have been, by and large, no different from the experiences of these parents. Most health care providers currently consider themselves extremely fortunate if they are able to coax, trick, or otherwise prompt a young child poisoning victim to ingest any amount of an activated charcoal antidote.
Faced with this obstacle, forced ingestion is not a viable option. Aside from its moral and legal implications, forced ingestion would pose a substantial collateral health risk. The direct health risks of activated charcoal therapy are nominal, if any, but one indirect risk, the serious occurrence of which has been reported in a few cases, is that of activated charcoal aspiration by the victim. While the risk of aspiration accompanies any oral ingestion of a substance, that risk is greatly amplified where ingestion of the substance is imposed upon a non-cooperative child who is instinctively resisting that ingestion. The risk becomes even greater when the ingestion is being forced by the child's parent, guardian, or any other individual having a personal relationship with the child, who might himself or herself understandably be in an excited, agitated, or even bewildered state given the exigencies surrounding a typical poisoning incident.
In cases where activated charcoal must be administered to an uncooperative patient, there is no choice but to introduce it through a nasogastric or orogastric tube. This procedure often requires physically restraining the patient. It also carries the risk of trauma to the mouth, pharynx, esophagus and stomach. Inadvertent placement into the tracheo-bronchial tree can result not only in trauma to these areas, but in massive charcoal aspiration which can be fatal.
Efforts have been made to render the currently available forms of activated charcoal more palatable, but those efforts have at best yielded only products that may be somewhat less noxious, but certainly not palatable, especially to young children. Still further, those efforts at times have led to the introduction of substances or components which may actually diminish the adsorptivity of the activated charcoal, thereby undermining the singular central function of the antidote.
What is currently needed, therefore, is an antidotal product containing ample quantities of activated charcoal which is palatable to young children and in which the adsorptivity of the activated charcoal is not diminished in any substantial measure. It is absolutely essential that the antidotal product not only be palatable enough to entice the average young child to place it into his or her mouth, but that the product also be palatable enough to encourage the child to willingly ingest adequate quantities thereof.
The method of the instant invention produces an antidotal food product containing activated charcoal which uniquely provides the necessary palatability not heretofore seen in prior art antidotes. The combination of particular binders, fillers, flavorings and sweeteners, in particular relative quantities and combined into a liquid slurry which is then processed in a spray dryer provides granules which when compressed together form a cookie-like wafer which has a consistency emulating that of a baked cookie. By virtue of the spray drying process step, each particulate is a combination of the multiple ingredients so that the filler, binder, flavoring and sweeteners are combined with the activated charcoal in each minute particulate of the wafer. To further add to the appeal and sweet flavor of the antidotal food product, such is manufactured in the form of a readily recognizable cookie sandwich having a pair of black wafers sandwiching a creamy filling. The subject antidotal food product in this form has the appearance, weight and feel of very common and popular cookie treats. To the average young child, the subject antidotal food product is, thus, indistinguishable from the delectable cookie treats he or she is accustomed to eating. In such a form, pharmacologically significant quantities of activated charcoal are readily ingested by young poisoning victims.
By virtue of the spray drying process, the binder is deposited on the external surface of the resulting granules, thereby promoting binder-to-binder contact during compaction in the compression molding step. As a result, a lower percentage of binder can be utilized to form the wafers, thereby enhancing the crumbly, cookie-like, texture of the finished wafers. Thus, a child would not only be enticed to place the subject antidotal food product into his or her mouth, he or she would actually be encouraged thereafter to chew and swallow the product, as such closely emulates the baked cookie treat the child is so familiar with. The pleasant taste further encourages the child to likewise ingest addition "activated charcoal cookies" which make up the required pharmacological activated charcoal dosage.
An important factor in the proper use of activated charcoal or any other decontaminant in toxicological treatment is, in addition to its ingestion in significant does by the victim, the promptness with which the ingestion occurs. Ideally, the activated charcoal ought to be administered at the site at which the poisoning incident occurs (which in most cases is the victim's home) immediately following the discovery of the accidental ingestion, before the ingested toxins have had the opportunity to be extensively absorbed into the bloodstream. Yet, most likely due to the difficulty of administering currently available activated charcoal antidotes, arising from their unpalatability, those antidotes are almost exclusively administered in medical institutions. Thus, many precious minutes, if not hours, after the accidental toxic ingestion has occurred, the victim is brought to the medical institution for treatment. In contrast, the antidotal food product formed by the inventive method, given its inherent palatability, could easily be administered in the home or any other setting outside a medical institution, and by any individual. Hence, the antidotal food product formed by the instant inventive method would not only expand the usage of activated charcoal as a decontaminant, but it would actually enhance, in a significant manner, the effectiveness of that usage.
The realization of a method for forming an antidotal food product which has a texture and taste which emulates that of a baked cookie product has been no trivial task. The development of the antidotal food product and the method for making such a product has required extensive testing and research. The inventive method described herein is a result of that extensive testing and research which has been carried out over a number of years.